Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: COPD Acute Exacerbation

In brief

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Key facts

Study ID: NCT06940154
Run by: Connect Biopharm LLC
People needed: 160
Starts: 2025-08-12
Expected to finish: 2026-08-27
Last updated by the study team: 2026-07-13

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Physician-diagnosed COPD with duration of ≥12 months.
Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
Current or former smoker with a history of smoking of ≥10 pack-years.
Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.

You may not qualify if…

Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit.
Known or suspected history of immunosuppression.
History of known immunodeficiency disorder or hepatitis B or C.
History of alcohol abuse and/or drug abuse.
Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day.
Participants on long-term macrolide.
Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening.
A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
Treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.
The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

Leland Stanford Junior University, Stanford Hospital — Palo Alto, California, United States
Amicis Research Center — Valencia, California, United States
National Jewish Health — Denver, Colorado, United States
Columbus Clinical Services, LLC — Miami, Florida, United States
Pharmax Research of South Florida, Inc. — Miami, Florida, United States
Health Synergy Clinical Research, LLC — West Palm Beach, Florida, United States
Primeway Clinical Research Group — Fayetteville, Georgia, United States
Pivotal Research Solutions — Stonecrest, Georgia, United States
University of Iowa — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Ochsner Medical Complex - The Grove — Baton Rouge, Louisiana, United States
Stony Brook University Hospital — Stony Brook, New York, United States
Duke Asthma, Allergy, and Airway Center — Durham, North Carolina, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
Inquest Clinical Research — Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials — McAllen, Texas, United States
Vermont Lung Center — Colchester, Vermont, United States
Carilion Medical Center / Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
Hospital Italiano de Buenos Aires — CABA, Buenos Aires, Argentina
CEMER - Centro Medico de Enfermedades Respiratorias — Florida, Buenos Aires, Argentina
Instituto Ave Pulmo-Fundacion Enfisema — Mar del Plata, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata — Mar del Plata, Buenos Aires, Argentina
University of Alabama at Birmingham Lung Health Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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